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Reducing Blood Loss During Cesarean Myomectomy With Tranexamic Acid

NCT03505502 — Not applicable, Completed, 120 participants, Aswan University Hospital

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Reducing Blood Loss During Cesarean Myomectomy With Intravenous Versus Topical Tranexamic Acid: a Double-blinded Randomized Placebo-controlled Trial

RegistryNCT03505502, acronym TA
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, prevention
Enrollment120 (Actual)
SponsorAswan University Hospital (Other)
ConditionsCesarean Section Complications
InterventionsIV tranexamic acid (Drug)
Datesstart 2018-01-01, primary completion 2020-01-01, completion 2020-03-01, first posted 2018-04-23, last updated 2020-03-20
Locations2 sites in Egypt

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-Summary

This study was a double-blinded randomized controlled study conducted at Aswan University, Egypt from January 2018 to January 2020. Study inclusion criteria were women who attended the outpatient obstetric clinic, seeking antenatal care diagnosed with leiomyomas with pregnancy and with myoma staging from (3 to 6) according to FIGO staging. scheduled to undergo cesarean myomectomy (11) Exclusion criteria were: 1-Patients undergone vaginal delivery.2-Patients with a history of thromboembolic disease. 3-Cervical and broad ligament myoma. 4-Myoma FIGO staging

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+Detailed description

Eligible participants were allocated to one of two groups after induction of anesthesia and immediately prior to the operation and just before skin incision. they received 1-gram tranexamic acid (10 ml) in 100 ml saline infusion or placebo (110 normal salines) by slow intravenous injection at an approximate rate of 1 mL per min. The abdomen was exposed through a midline or Pfannenstiel incision, after skin incision, the subcutaneous fat and abdominal fascia were opened crosswise, and the rectus muscle was opened on the midline. The parietal peritoneum was opened longitudinally to reach the pelvic cavity. Uterus was inspected for a number, location, and shape of myomas and other pelvic organs were inspected for associated pathology. a lower uterine incision will be performed to deliver the baby and Uterine incisions on top of myoma were performed. The incision was performed using monopolar diathermy. Intracapsular enucleation of myomas was performed by gently dissecting between the myoma and the pseudo-capsule. The myoma was grasped by Collins forceps and gently enucleated out.,. Myoma bed was closed by 1 or 2 layers of interrupted vicryl sutures (Vicryl 1-0 polyglactin 910; Egycryl, Taisier CO, Egypt). At the end of the surgery, 1 intraperitoneal suction drain was routinely used in all patients the drains were removed on the second postoperative day unless otherwise indicated. Number and size of myomas were recorded. Myoma size represented the mean size of each myoma. Enucleated myomas were sent to histopathology.

Blood loss estimation Intraoperative blood loss was measured by adding the volume of the contents of the suction bottle and the difference in weight (in grams) between the dry and the soaked operation sheets and towels (1 gram = 1 ml.). Post-operative blood loss was measured through intraperitoneal suction drain which measured every 12 hours and on removing the drain. After that, the total blood loss was calculated by the addition of intraoperative and postoperative blood loss.

+Arms and interventions

ArmTypeInterventionsDescription
placebo armPlacebo comparatorDrug: IV tranexamic acidgroup receive i/v saline plus irrigation of the myoma bed with normal saline
IV tranexamic acid groupExperimentalDrug: IV tranexamic acidgroup received IV tranexamic 1gm in normal saline
topical tranexamic acid groupActive comparatorDrug: IV tranexamic acidgroup received topical tranexamic 2gm in normal saline
  • IV tranexamic acid (Drug), also known as Topical tranexamic acid: in IV tranexamic acid group they received 1-gram tranexamic acid (10 ml) in 100 ml saline infusion or placebo (110 normal saline) by slow intravenous injection at an approximate rate of 1 mL per min.In topical tranexamic acid groupA gauze soaked with 2g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride 0.9% or placebo (120ml of sodium chloride 0.9%.) used to compress the myoma bed for 5 minutes. To ensure a sufficiently high concentration, the tranexamic acid was diluted only to a volume sufficient to moisten a large wound surface. 20 ml moisten at least 1500 cm2.

+Outcome measures

Primary outcomes

  • estimation of intraoperative blood loss (ml). [intraoperative]: Intraoperative blood loss was measured suction bottle and the difference in weight (in grams) between the dry and the soaked operation sheets and towels (1 gram = 1 ml.). Post-operative blood loss was measured through intraperitoneal suction drain which measured every 12 hours and on removing the drain. After that, the total blood loss was calculated by the addition of intraoperative and postoperative blood loss.and vaginal bleeding

Secondary outcomes

  • need for blood transfusion [24 hours postoperative]: need for blood transfusion
  • Hemoglobin concentration [ist 24 hours postoperative]: pre and postoperative hemoglobin estimation
  • operative time [operative time]: operative time

+Eligibility

Sex: Female, ages: 18 Years to 40 Years

Inclusion Criteria:

* women who attended the outpatient gynecology clinic, seeking treatment for symptomatic leiomyomas and scheduled to undergo abdominal myomectomy with myoma staging from (3 to 6) according to FIGO staging

Exclusion Criteria:

1. Patients undergone vaginal or laparoscopic myomectomy.
2. Patients received preoperative embolization or gonadotrophin releasing hormone analog.
3. Cervical and broad ligament myoma.
4. Patients with cardiac, hepatic, renal or thromboembolic disease
5. patients had an allergy to tranexamic acid).

+Locations (2)

FacilityCityCountryStatus
AswanUHAswānEgypt
AswanUHAswānEgypt

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